Real-world use of trifluridine/tipiracil for patients with metastatic colorectal cancer in Canada

Background Outcomes for patients with metastatic colorectal cancer (MCRC) are improving with the introduction of new treatments. Treatment for patients who are still fit after failure of all available therapies represents a significant unmet need. In the present study, we analyzed real-world treatment patterns for patients enrolled in Health Canada's trifluridine/tipiracil (FTD/TPI) Special Access Program (SAP) and Taiho Pharma Canada's Patient Support Program (PSP). Methods Demographic information and clinical treatment data were collected from adults with MCRC who were previously treated with, or were not candidates for, available therapies and who were enrolled in the SAP and PSP. For all patients, FTD/TPI treatment status, discontinuation reasons, and prior therapies were examined. Results The analysis included 717 Canadian patients enrolled in the FTD/TPI SAP and PSP from September 2017 to October 2018. In that cohort, 59.7% were men, median age was 65 years, and median duration of therapy was 77 days (25%-75% interquartile range: 43-106 days). Of treated patients, 67.1% maintained the same dose for the duration of therapy; 28.0% had a dose reduction. On multivariable analysis, duration of therapy was not influenced by sex, age, province, RAS mutation status, or prior therapies. However, prior oxaliplatin-based chemotherapy (CAPOX or FOLFOX) appeared to be associated with higher rates of discontinuation because of death or disease progression. Conclusions In advanced MCRC, FTD/TPI is a well-tolerated therapy. The large number of patients enrolled in the access programs within a short period of time is reflective of major clinical need in this area, with many patients being eligible and interested in pursuing treatment in the refractory setting.